Bio Pharma Dive
OCTOBER 17, 2023
One month after Roche’s Genentech inked a similar deal, the Swiss pharma is now paying $50 million to work with Monte Rosa on molecular glue medicines for cancer and neurological diseases.
Pharmaceutical Technology
OCTOBER 17, 2023
In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.
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Bio Pharma Dive
OCTOBER 17, 2023
Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.
Pharmaceutical Technology
OCTOBER 17, 2023
As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.
Bio Pharma Dive
OCTOBER 17, 2023
The Danish drugmaker's innovation hub in Boston has teamed up with the Broad Institute, Mass General Brigham, Harvard and Yale, expanding its research into cardiometabolic diseases.
Pharmaceutical Technology
OCTOBER 17, 2023
SpliceBio will license Spark Therapeutics’ propriety protein splicing platform to develop a gene therapy for renal disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
OCTOBER 17, 2023
The Merck drug leads competitors Opdivo and Imfinzi into a new immunotherapy setting, which aims to improve outcomes following the surgical removal of tumors.
Pharmaceutical Technology
OCTOBER 17, 2023
The extended agreement will focus on developing checkpoint inhibitors in cancer, with two anti-PD1 antibodies in preclinical development.
Bio Pharma Dive
OCTOBER 17, 2023
Tuesday’s earnings were the first since J&J officially split off its consumer drug business, now the publicly traded company Kenvue.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2023
The Indian Council of Medical Research (ICMR) has invited expression of interest (EOI) from Indian scientists and researchers to accelerate screening, early diagnosis and treatment of cancer at the district level.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
OCTOBER 17, 2023
The US BARDA contract will sponsor the development of the company’s plasma gelsolin for treating acute respiratory distress syndrome.
Rethinking Clinical Trials
OCTOBER 17, 2023
What Are the Reasons to Randomize Clusters Instead of Individuals? Description Dr. Liz Turner discusses the reasons to randomize clusters instead of individuals. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post What Are the Reasons to Randomize Clusters Instead of Individuals?
Pharmaceutical Technology
OCTOBER 17, 2023
LegoChem Biosciences has entered an exclusive worldwide licensing agreement with Glycotope to develop an antibody-drug conjugate (ADC).
Rethinking Clinical Trials
OCTOBER 17, 2023
What Is Outcome Clustering, and How Can It Affect a Trial? Description Dr. Liz Turner discusses outcome clustering and how it can affect a trial. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post What Is Outcome Clustering, and How Can It Affect a Trial?
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Pharmaceutical Technology
OCTOBER 17, 2023
The US FDA has granted a priority review to the sNDA filed by AstraZeneca for its Tagrisso (osimertinib) along with chemotherapy
Rethinking Clinical Trials
OCTOBER 17, 2023
What Is the Intraclass Correlation Coefficient? Description Dr. Liz Turner discusses the intraclass correlation coefficient. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post What Is the Intraclass Correlation Coefficient? appeared first on Rethinking Clinical Trials.
Pharmaceutical Technology
OCTOBER 17, 2023
The Netherlands-based company’s treatment has been awarded the designation by the US FDA following a successful Phase I trial.
Rethinking Clinical Trials
OCTOBER 17, 2023
How Does Clustering Affect Power and Detectable Difference? Description Dr. Liz Turner discusses how clustering affects power and detectable difference. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post How Does Clustering Affect Power and Detectable Difference?
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
OCTOBER 17, 2023
Novo Nordisk has signed an agreement to acquire ocedurenone for uncontrolled hypertension from KBP Biosciences for $1.3bn.
Rethinking Clinical Trials
OCTOBER 17, 2023
How Do You Estimate the Degree of Clustering for Outcomes? Description Dr. Liz Turner discusses how to estimate the degree of clustering for outcomes. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post How Do You Estimate the Degree of Clustering for Outcomes?
Pharmaceutical Technology
OCTOBER 17, 2023
The latest Keytruda/chemotherapy approval marks the sixth setting in NSCLC where the PD-1 inhibitor is FDA-approved.
Rethinking Clinical Trials
OCTOBER 17, 2023
What Are the Challenges of Using Data Directly From the EHRs? Description Dr. Rachel Richesson discusses the challenges of using data directly from the EHRs. Speaker Rachel Richesson, PhD Professor of Learning Health Sciences, University of Michigan Medical School Electronic Health Records Core Co-chair The post What Are the Challenges of Using Data Directly From the EHRs?
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
OCTOBER 17, 2023
Vaxcyte has signed a new commercial agreement with Lonza for the global manufacture of broad-spectrum PCVs.
Rethinking Clinical Trials
OCTOBER 17, 2023
What Is A Computable Phenotype? Description Dr. Rachel Richesson discusses computable phenotypes. Speaker Rachel Richesson, PhD Professor of Learning Health Sciences, University of Michigan Medical School Electronic Health Records Core Co-chair The post What Is A Computable Phenotype? appeared first on Rethinking Clinical Trials.
Fierce Pharma
OCTOBER 17, 2023
Editor's note: This is an evolving story. Please check back on Oct. 23 when the full data of MARIPOSA are presented at ESMO 2023. | A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.
Rethinking Clinical Trials
OCTOBER 17, 2023
What Are the Benefits to Standardizing Phenotype Definition? Description Dr. Rachel Richesson discusses the benefits to standardizing phenotype definition. Speaker Rachel Richesson, PhD Professor of Learning Health Sciences, University of Michigan Medical School Electronic Health Records Core Co-chair The post What Are the Benefits to Standardizing Phenotype Definition?
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Fierce Pharma
OCTOBER 17, 2023
If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.
Rethinking Clinical Trials
OCTOBER 17, 2023
What Are the Key Factors in Using EHR Data for Endpoints and Outcomes? Description Dr. Rachel Richesson discusses the key factors in using EHR data for endpoints and outcomes. Speaker Rachel Richesson, PhD Professor of Learning Health Sciences, University of Michigan Medical School Electronic Health Records Core Co-chair The post What Are the Key Factors in Using EHR Data for Endpoints and Outcomes?
Pharma Times
OCTOBER 17, 2023
The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes
Rethinking Clinical Trials
OCTOBER 17, 2023
What Are the Types of CRT Designs? Description Dr. Liz Turner discusses the types of CRT designs. Speaker Liz Turner, PhD Associate Professor, Biostatistics and Bioinformatics and Global Health Biostatistics and Study Design Core Co-Chair The post What Are the Types of CRT Designs? appeared first on Rethinking Clinical Trials.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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